Clinical trial · Interventional
Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02
NCT06780358CI-TRIAL-00084854RAISE02enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being conducted to investigate if an artificial intelligence support tool is non-inferior in detecting bladder cancer compared to the traditional method, standard white light cystoscopy (WLC). The researchers will compare how well the artificial intelligence tool and WLC perform in detecting bladder cancer through a controlled, organized testing process.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI supported detection of bladder cancer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- WLC detection
- description
- Detection of bladder cancer is conducted according to state-of-the-art procedures in white light modality.
- type
- EXPERIMENTAL
- label
- AI model - WLC supported detection
- description
- Detection of bladder cancer in white light supported by a pre-market AI-support tool.
- interventionNames
- Device: AI supported detection of bladder cancer
Primary outcomes (1)
- measure
- Sensitivity of standard WLC compared to WLC assisted by the AI model evaluated with a non-inferiority margin of 5%.
- timeFrame
- 7 month
- description
- To determine whether the AI model is non-inferior with regards to sensitivity compared to standard WLC in a randomized controlled trial.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women adults, age \>18 years old Suspicion of primary or recurrent bladder cancer Willingness to sign the Informed Consent Form (ICF) for the CI Ability to comprehend the oral and written Patient Information Leaflet (PIL) Exclusion Criteria: * Not able or willing to sign the Informed Consent Form
References
Publications (0)
Data not yet available
No reference posted for this study.